ACETAMINOPHEN; BUTALBITAL - Generic Drug Details
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What are the generic drug sources for acetaminophen; butalbital and what is the scope of freedom to operate?
Acetaminophen; butalbital
is the generic ingredient in twenty branded drugs marketed by Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Granules, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, Taro, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, and Nostrum Labs Inc, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.Eleven suppliers are listed for this compound.
Summary for ACETAMINOPHEN; BUTALBITAL
| US Patents: | 0 |
| Tradenames: | 20 |
| Applicants: | 39 |
| NDAs: | 82 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 3 |
| Patent Applications: | 8 |
| DailyMed Link: | ACETAMINOPHEN; BUTALBITAL at DailyMed |
Recent Clinical Trials for ACETAMINOPHEN; BUTALBITAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| GlaxoSmithKline | Phase 3 |
Pharmacology for ACETAMINOPHEN; BUTALBITAL
| Drug Class | Barbiturate |
US Patents and Regulatory Information for ACETAMINOPHEN; BUTALBITAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | CAPSULE;ORAL | 040261-001 | Oct 28, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Quagen | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | TABLET;ORAL | 214287-001 | Jan 18, 2024 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Labs Ut Inc | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | acetaminophen; butalbital; caffeine | TABLET;ORAL | 088616-001 | Nov 9, 1984 | AA | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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